Simultaneous Application of High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Changes in Subcutaneous Fat Tissue and Muscle Toning of Thighs

BTL Industries Ltd.4 sites in 1 country93 target enrollmentSeptember 15, 2020

ConditionsFat Burn

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Fat Burn
Sponsor: BTL Industries Ltd.
Enrollment: 93
Locations: 4
Primary Endpoint: Evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the clinical efficacy and safety of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for changes in subcutaneous fat tissue and muscle toning of thighs.

Registry

clinicaltrials.gov

Start Date

September 15, 2020

End Date

January 20, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

BTL Industries Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age \> 21 years
•Voluntarily signed an informed consent form
•BMI ≤ 35 kg/m2
•Women of child-bearing potential are required to use birth control measures during the whole duration of the study
•Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
•Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation

Exclusion Criteria

•Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
•Metal implants
•Drug pumps
•Malignant tumor
•Pulmonary insufficiency
•Injured or otherwise impaired muscles
•Cardiovascular diseases
•Disturbance of temperature or pain perception
•Hemorrhagic conditions
•Septic conditions and empyema

Outcomes

Primary Outcomes

Evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging

Time Frame: 7 months

The primary objective of the study is to determine the effectiveness of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for change in the adipose layer thickness between pre-treatment and post-treatment based on MRI imaging. The changes will be considered statistically significant where p-value \<0.05.

Secondary Outcomes

Assess safety profile by recording of adverse events(7 months)
Assess subjects' satisfaction with the treatment using Subject Satisfaction Questionnaire(7 months)